Safety/Tolerability, Immunological and Clinical Activity of a Boost Immunization With AFFITOPE AD02

Phase IB Follow-up Study to Assess a Boost Immunization With AFFITOPE AD02 With Regard to Safety/Tolerability, Immunological and Clinical Activity in Alzheimer Patients Who Have Received the Vaccine Within the Clinical Study AFF002

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01093664

Enrollment

Registered

2010-03-26

Start date

2009-10-31

Completion date

2010-07-31

Last updated

2010-10-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Alzheimer's Disease

Brief summary

This is a phase IB follow-up study to assess a boost immunization with AFFITOPE AD02 with regard to safety/tolerability, immunological and clinical activity in Alzheimer patients who have received the vaccine within the clinical study AFF002.

Interventions

BIOLOGICALAFFITOPE AD02

s.c. injection

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

50 Years to 85 Years

Healthy volunteers

Inclusion criteria

* Participation in AFF002 and AFF004

Exclusion criteria

* Presence or history of allergy to components of the vaccine, if considered relevant by the investigator * Contraindication for MRI imaging * History and/or presence of autoimmune disease, if considered relevant by the investigator * Active infectious disease (e.g., Hepatitis B, C) * Presence and/or history of Immunodeficiency (e.g., HIV) * Significant systemic illness

Design outcomes

Primary

Measure	Time frame	Description
Safety and Tolerability	July 2010	* Withdrawal criteria (continuation decision) Number of patients who withdraw due to AEs Reason for withdrawal * Adverse events (AEs) * Serious adverse events (SAEs) * Physical and neurological examination * Concomitant medication * Vital signs (blood pressure, heart rate, respiratory rate, body temperature) * Body mass (weight and height) * MRI of brain * ECG * Laboratory assessment (haematology, biochemistry, coagulation, serology and urinalysis)

Secondary

Measure	Time frame	Description
Immunological and clinical activity	July 2010	Immunological parameters: \- Assessment of the immune response triggered by the vaccine (titre of IgG antibodies specific for the immunizing peptide, N-terminal part of Aβ, (irrelevant peptide serves as specificity control), Aβ itself and KLH as assessed by ELlSA as well as the results of the biacore affinity measurements towards the immunizing peptide and Aβ) Clinical efficacy variables: * Cognitive and functional tests, behavioural scales * Measurement of quality of life in patients with Alzheimer's disease * Investigator's global evaluation scale

Countries

Austria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026